Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06622252
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-09-03
Brief Title:
Intervention Development and Evaluation to Reduce Disparities in Quality of Life for Latino Families Impacted by Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Intervention Development and Evaluation to Reduce Disparities in Quality of Life for Latino Families Impacted by Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if a culturally relevant caregiver intervention is effective in decreasing stress and improving quality of life in Spanish speaking Latino caregivers of children diagnosed with cancer compared to a control group
Detailed Description:
Phase 1
Following informed consent participants will be asked to complete measures at baseline post interventionT2 and 3 months post intervention T3 Once baseline questionnaires are completed subjects will participate in a 13-week intervention comprised of live sessions aimed to address the components of health literacy caregiver wellness and culturally competent care Content of the sessions include culinary medicine psycho-education complementary alternative medicine gardening dance-based movement question-answer forums and spirituality
Participants will have access to a study specific a site which host recordings of all intervention sessions delivered throughout the intervention period and will track frequency and duration of video usage Additionally participants will have the opportunity to connect with each other outside of weekly sessions using the chat feature within the video hosting platform
All parts of the 13-session intervention will be delivered virtually via Zoom to ensure accessibility Sessions will be scheduled on the dates and times most convenient for participants to encourage regular caregiver attendance Zoom links will be shared with participants on a weekly basis via text or email All sessions will be delivered in Spanish by native Spanish speakers with the exception of week 7 of the intervention A translator will be present to facilitate this session
Sessions are intended for caregivers specifically however other members of the family may join if they choose to Sessions may require supplies for participant participation and engagement In these circumstances the research team will provide supply kits to each participant Additionally participants will be loaned tablets as well as mobile hotspots throughout the intervention period to ensure equal opportunity for participation in this virtual pilot intervention A member of the research team will be present at each session taking notes and assisting with any technical issue that may arise
Immediately following the program caregivers will be asked to participate in focus group or individual interview qualitative and to complete a measure of content and usability quantitative In addition the investigators will also interview our session expertspresenters to get their overall impressions of their intervention component These interviews will be audio recorded
Phase 2
Procedures for phase 2 will remain the same for participants randomized to the intervention group However participants in the control group will only be asked to complete study questionnaires To allow equal opportunity to control participants caregivers will have the opportunity to attend intervention sessions after the 3 month follow up surveys are completed Caregivers will not be compensated for attendance and sessions will not be recorded at this point
Following informed consent participants will be asked to complete measures at baseline post interventionT2 and 3 months post intervention T3 Once baseline questionnaires are completed subjects will participate in a 13-week intervention comprised of live sessions aimed to address the components of health literacy caregiver wellness and culturally competent care Content of the sessions include culinary medicine psycho-education complementary alternative medicine gardening dance-based movement question-answer forums and spirituality
Participants will have access to a study specific a site which host recordings of all intervention sessions delivered throughout the intervention period and will track frequency and duration of video usage Additionally participants will have the opportunity to connect with each other outside of weekly sessions using the chat feature within the video hosting platform
All parts of the 13-session intervention will be delivered virtually via Zoom to ensure accessibility Sessions will be scheduled on the dates and times most convenient for participants to encourage regular caregiver attendance Zoom links will be shared with participants on a weekly basis via text or email All sessions will be delivered in Spanish by native Spanish speakers with the exception of week 7 of the intervention A translator will be present to facilitate this session
Sessions are intended for caregivers specifically however other members of the family may join if they choose to Sessions may require supplies for participant participation and engagement In these circumstances the research team will provide supply kits to each participant Additionally participants will be loaned tablets as well as mobile hotspots throughout the intervention period to ensure equal opportunity for participation in this virtual pilot intervention A member of the research team will be present at each session taking notes and assisting with any technical issue that may arise
Immediately following the program caregivers will be asked to participate in focus group or individual interview qualitative and to complete a measure of content and usability quantitative In addition the investigators will also interview our session expertspresenters to get their overall impressions of their intervention component These interviews will be audio recorded
Phase 2
Procedures for phase 2 will remain the same for participants randomized to the intervention group However participants in the control group will only be asked to complete study questionnaires To allow equal opportunity to control participants caregivers will have the opportunity to attend intervention sessions after the 3 month follow up surveys are completed Caregivers will not be compensated for attendance and sessions will not be recorded at this point
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None